A Study of MK0653A (Ezetimibe (+) Simvastatin) in Patients With Hypercholesterolemia (0653A-038)

Phase 3

Completed

• Conditions: Hypercholesterolemia

• Registration Number: NCT00092651
• Lead Sponsor: Organon and Co

Brief Summary

The purpose of this study is to evaluate the lipid lowering effects of an investigational drug in patients with hypercholesterolemia (high cholesterol).

Detailed Description

The duration of treatment is 4 months.

Study Timeline

• Study Start: 2002-09
• Primary Completion: 2003-06
• Study Completion: 2003-06
• Study First Submitted: 2004-09-23
• Study First Submitted QC: 2004-09-27
• Study First Posted: 2004-09-28
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1398

Inclusion Criteria

• High cholesterol

Exclusion Criteria

• Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Plasma LDL-C	From baseline to study end point, defined in this study as the last available postbaseline LDL-C measurement, after 12 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Plasma LDL-C, TG and HDL-C. The proportion of patients achieving LDL-C targets. Tolerability.	From baseline to study end point in TC, TG, HDL-C, ratios of direct LDL-C:HDL-C and TC:HDL-C, non-HDL-C, Apo B, Apo A-I, Apo A-II, Apo E, lipoprotein(a), C[1]reactive protein (CRP), and fibrinogen, after 12 weeks of treatment.